MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PERFORMANCE PRO AMBULANCE COT; STRETCHER, WHEELED

Catalog Number 6086000000

Device Problem Use of Device Problem (1670)

Patient Problem Crushing Injury (1797)

Event Date 02/25/2019

Event Type  Injury  

Manufacturer Narrative

A review of the device operations manual identified that all hands should be kept clear of the safety bar when unloading the cot.The user facility agreed with this information and stated they will be more careful in the future.

Event Description

It was reported that the safety bar created a pinch/crush point, cutting the paramedics hand.The injury occurred due to the paramedic reaching underneath the safety bar as the cot was being unloaded from the ambulance.When the cot was released, the bar created a pinch/crush point, cutting the paramedics hand.The user facility confirmed the paramedic required stitches as a result of this event.

• Brand Name: PERFORMANCE PRO AMBULANCE COT
• Type of Device: STRETCHER, WHEELED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 8463639
• MDR Text Key: 140276544
• Report Number: 0001831750-2019-00288
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327261554
• UDI-Public: 07613327261554
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 6086000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1